- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07636330
Virtual Reality for Pain and Anxiety in Pediatric Dental Treatment
Effects of Immersive Virtual Reality on Pain, Anxiety, and Post-Procedural Experience in Pediatric Dental Treatment: A Randomized Controlled Trial
The goal of this clinical trial is to learn whether immersive virtual reality (VR) reduces pain and anxiety in children aged 6-12 years during routine dental procedures. The main questions it aims to answer are:
- Does VR distraction reduce self-reported pain and anxiety during dental treatment compared to standard behaviour guidance?
- Does VR distraction improve children's post-procedural experience and willingness to return for future dental visits?
Researchers will compare children using a VR headset during dental treatment to children receiving standard behaviour guidance techniques.
Participants will:
- Attend one routine dental appointment
- Be randomly assigned to wear a VR headset or receive standard care during their procedure
- Complete brief questionnaires about pain and anxiety before and after treatment
- Receive a follow-up phone call 24-72 hours after the appointment
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Randa Soussou
- Numéro de téléphone: 604-822-6819
- E-mail: randa.soussou@dentistry.ubc.ca
Lieux d'étude
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British Columbia
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Vancouver, British Columbia, Canada, V6T 1Z3
- UBC Graduate Pediatric Dental Clinic
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Contact:
- Randa Soussou
- Numéro de téléphone: 604-822- 6819
- E-mail: randa.soussou@dentistry.ubc.ca
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
La description
Inclusion Criteria:
- Children aged 6 to 12 years
- Scheduled for a routine invasive dental procedure
- Accompanied by a parent or legal guardian
- Parent/guardian able to provide written informed consent
Exclusion Criteria:
- Children with visual or hearing impairments that would prevent use of the VR headset
- Children with a history of motion sickness
- Children with severe cognitive or developmental delays that would prevent completion of study measures
- Children who have previously participated in this study
- Children requiring emergency dental treatment
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: VR Distraction
Children wear an immersive VR headset during routine dental treatment as a non-pharmacological distraction intervention.
The VR headset provides an engaging visual and auditory environment to reduce pain and anxiety during the procedure.
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A commercially available immersive VR headset used as a non-pharmacological distraction tool during routine pediatric dental procedures.
Children wear the headset throughout their treatment to engage with an interactive virtual environment designed to reduce pain and anxiety.
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Comparateur actif: Standard Behaviour Guidance
Children receive standard behaviour guidance techniques commonly used in pediatric dentistry, such as tell-show-do and positive reinforcement, without VR distraction.
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Standard behaviour guidance techniques routinely used in pediatric dentistry, including tell-show-do, positive reinforcement, and distraction through verbal communication and a TV screen.
No virtual reality headset is used.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Self-Reported Pain During Dental Procedure Using Faces Pain Scale
Délai: Baseline Pre-procedural and Immediately following the dental procedure (same day)
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Child self-reported pain assessed using the Faces Pain Scale (0-10 where 10 is the maximum pain felt): The child is asked to point to the Faces picture that reflect the pain level that they are feeling.
0= Relaxed and comfortable; 2-4= Mild discomfort; 6-8= Moderate pain; 10= Severe pain or discomfort Baseline pre-procedural and immediately following the dental procedure.
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Baseline Pre-procedural and Immediately following the dental procedure (same day)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Physiological Stress Response (Heart Rate)
Délai: Baseline (Before the procedure), during and Immediately following the dental procedure
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Physiological markers of stress assessed via heart rate using a pulse oximeter device (pulse/minute)
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Baseline (Before the procedure), during and Immediately following the dental procedure
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Physiological Stress Response (Salivary alpha-Amylase) salivary alpha-amylase level (U/L) baseline before any dental treatment and immediately following the dental procedure
Délai: Salivary alpha-amylase level (U/L), measured at baseline (immediately prior to the start of the dental procedure) and again immediately following the dental procedure. Both samples are collected on the same day, during the single dental appointment.
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Using a swab to collect for a full 60-90 seconds by resting the swab inside the mouth, or collect in intervals by re-introducing the swab into the mouth as needed, until the lower third of the swab is saturated (some participants may require longer than 90 seconds of total collection time).
Salivary alpha-amylase level (U/L), measured at baseline (immediately prior to the start of the dental procedure) and again immediately following the dental procedure.
Both samples are collected on the same day, during the single dental appointment.
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Salivary alpha-amylase level (U/L), measured at baseline (immediately prior to the start of the dental procedure) and again immediately following the dental procedure. Both samples are collected on the same day, during the single dental appointment.
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- H25-03739 (Autre identifiant: UBC Clinical Research Ethics Board)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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